Phase 2
N=46
An Exploratory Haemodynamic Study in Patients With Compensated Cirrhosis and Portal Hypertension
Compensated Cirrhosis and Portal Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01640964 ↗Enrolled (actual)
46
Serious AEs
8.7%
Results posted
Jan 2016
Primary outcome: Primary: Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) — 0.438 L/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Terlipressin acetate (Drug); Serelaxin (RLX030) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only)) |
0.438 | — |
| PRIMARY Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B) |
-1.2 | — |
| SECONDARY Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only)) |
0.059 | — |
| SECONDARY Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only)) |
0.084 | — |
| SECONDARY Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only)) |
0.002 | — |
| SECONDARY Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only)) |
0.293 | — |
| SECONDARY Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only)) |
-0.091 | — |
| SECONDARY Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B) |
-3.7 | — |
| SECONDARY Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin |
3; 3; 1; 2; 0; 0 | — |
Summary
The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).
Eligibility Criteria
Inclusion Criteria
Study Parts A and B:
-Cirrhosis of alcohol aetiology according to physician's assessment prior to screening.
Part A:
-Cirrhosis with clinical and/or endoscopic evidence of portal hypertension (e.g. oesophageal varices).
Part B:
- Cirrhosis with TIPSS in situ and PPG>5mmHg.
- Fully functioning TIPSS without variceal filling as confirmed by portography.
Exclusion Criteria
Study Parts A and B:
- Use of any drug to treat portal hypertension (e.g. vasodilators such as non-selective beta blockers or nitrates) within 1 month prior to screening.
- Decompensated cirrhosis (Child-Pugh score >9 points, and/or ascites requiring diuretics, and/or hepatic encephalopathy) at visit 1.
- Presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Part A:
- BMI (weight[kg] / height[m^2]) > 40 kg/m^2.
- Any contraindication to having an MRI scan
Part B:
-Contraindication to catheterization
Data sourced from ClinicalTrials.gov (NCT01640964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.